MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERITONEAL CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number PERITONEAL CATHETER

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

Title: the ¿pull¿ technique for removal of peritoneal dialysis catheters: a call for re-evaluation of practice standards: source: marvin grieff et al., 2016 august 26.If information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event Description

According to the literature source of study performed from an 18-month period, between january 2014 and june 2015, peritoneal dialysis catheter removal by the ¿pull¿ technique which was at the bedside of the hospitalized patient.Peritoneal dialysis catheters reviewed in this study were all double-cuffed coiled tenckhoff catheters with three (3) complications among 46 catheter removals using this technique.One patient retained the superficial cuff which became infected 9 months after the catheter was removed.The second complication was noted in a patient in whom the catheter was placed with an extension using a titanium connector.Removal of the catheter by pulling led to separation of the two segments at the site of the connector, and the deeper catheter segment had to be removed surgically.The third complication occurred in a patient with liver disease who had a leak of ascitic fluid.It was concluded that the ¿pull¿ technique was a safe method for tenckhoff catheter removal with low risk of infection and was strongly recommend as the procedure of choice.

• Brand Name: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8671682
• MDR Text Key: 147092278
• Report Number: 3009211636-2019-00137
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PERITONEAL CATHETER
• Device Catalogue Number: PERITONEAL CATHETER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other